Senior Quantitative Pharmacologist

Regeneron Pharmaceuticals•Warren, MA

7d•Hybrid

About The Position

As a Senior Quantitative Pharmacologist, this individual is expected to provide significant contributions to Pharmacometrics deliverables in support of multiple programs while also developing an ability to understand the strategic positioning for these programs in Pharmacometrics as well as across the organization. Through the application of state-of-the-art knowledge in pharmacokinetics and pharmacodynamics, this role is responsible for the execution of PK, PD, and other types of quantitative analyses that significantly contribute to the development of multiple programs.

Requirements

PhD in Quantitative Pharmacology, Pharmacometrics, Engineering, or a related field with 3+ years of experience
Demonstrated expertise in population PK/PD, exposure–response, or mechanistic modeling (systems biology, or QSP) using tools such as NONMEM, Monolix, Simulx, MATLAB/Simbiology and R.
Hands-on experience with a broad range of quantitative and computational tools and a strong publication record.
Exceptional communication and interpersonal skills, with the ability to influence and partner effectively across technical and non-technical teams.

Responsibilities

Collaborate across functions to plan, design, implement, and analyze pharmacometrics (PMx) studies supporting drug development programs.
Apply standardized scientific approaches to evaluate and interpret in vitro and in vivo pharmacokinetic (PK), pharmacodynamic (PD), and PK/PD data.
Conduct a broad range of quantitative analyses including NCA, compartmental modeling, population PK, exposure-response, translational, and disease modeling.
Interpret study results and develop scientifically sound conclusions and recommendations to support development decisions.
Prepare accurate, timely, and well-articulated study reports, technical summaries, and regulatory submission documents.
Partner with PMx Research Specialists, programmers, statisticians, and scientific writers to develop tables, figures, listings (TFLs), and supporting analyses for internal and regulatory deliverables.
Contribute PMx expertise to Research and Global Clinical Study Team (GCST) meetings, including input on study design, analysis strategy, and interpretation of results.
Support regulatory interactions by preparing analyses and background materials for agency meetings, including pre-IND, End-of-Phase 2, and pre-BLA submissions.
Monitor project timelines, deliverables, and completion of assigned tasks; may serve as the PMx representative on cross-functional development teams with appropriate guidance.
Maintain compliance with PMx operating procedures, quality standards, and the company's code of ethical conduct.